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    Merken
    Figure 1: Extracted ion chromatograms (EIC) of the reaction products of selected electrophile extractable standards with glutathione (GSH). A) displays the reaction product of acrylic acid with GSH. The EIC was generated with the calculated mass of 380.1122 amu (MH+). B) displays the reaction product of GSH with formaldehyde at a calculated mass of 338.2 amu (MH+). C) depicts the reaction product of GSH with allyl bromide with a calculated mass of 346.1063 amu (M-H). D) shows the reaction product of bisphenol-A-diglycidyl ether with GSH with a calculated mass of 666.2690 amu (MH+). All mass data were obtained by high resolution accurate mass spectrometry and the mass differences observed between calculated and determined molecular weight was < 5 ppm. With the exception of the formaldehyde reaction product which was determined by low resolution mass spectrometry. The mass difference between the calculated and the determined mass is < 0.4 amu. The allyl bromide reaction product was determined in negative polarity ion mode (Source: All figures were made by the authors/A&M STABTEST GmbH).

    Protein-Reactive Extractables

    A Screening Assay Which Adds Additional Value to the Traditional E/L Workflow

    Originale

    1. Introduction
    2. Materials
    3. Methods
    4. Results and Discussion
    5. Summary
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    Key Words , Extractable , Leachable , Product Quality Research Institute (PQRI) , protein-reactive , rubber oligomer , polysulfanes

    Ramona Haep, André Stratmann, Steven A. Watt, Lejon Martens · A&M STABTEST GmbH, Bergheim

    Correspondence:

    Steven A. Watt, A&M STABTEST GmbH, Kopernikusstr. 6, 50126 Bergheim, Germany; e-mail: steven.watt@am-labor.de

    Abstract

    Extractable and leachable studies performed on the immediate container closure system for biopharmaceutical drug products are well established in the pharmaceutical industry with best practice guidances and guidelines which outline what is expected and acceptable. Studies adhering to these guidances address the potential of an extractable or leachable to have a direct toxic or genotoxic effect. However, there are only few studies published on the (...)